ACCLARENT, INC. RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK; INSTRUMENT, ENT MANUAL SURGICAL
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Catalog Number RSP0616MFS |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/16/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The patient¿s gender is not known.The patient's weight is not known.The lot number of the device is not known.Full udi # information unavailable since the lot number is unavailable.The lot history record review could not be performed as lot number for the acclarent relieva spinplus device was unavailable.If additional information is received regarding this event, a supplemental report will be filed.(b)(4).
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Event Description
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Acclarent was informed on (b)(4) 2017, for an event that occurred on (b)(6) 2017 involving a relieva spinplus kit, 3 guides, 6 mm, 5pk (lot# not available).During a primary balloon sinuplasty procedure, the tip of the balloon catheter fully separated and detached from the balloon.It was retrieved while it was still on the guidewire.There was no report of any patient consequence.Another device was opened and the procedure was resumed and subsequently completed.
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